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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2017/02/007770
Date of registration: 03-02-2017
Prospective Registration: No
Primary sponsor: Nethradhama Superspeciality Eye Hospital
Public title: Correlating Glaucomatous damage with a glaucoma test index called Visual field index
Scientific title: Correlating Visual Field Index with stages of Glaucomatous visual field damage
Date of first enrolment: 01-09-2015
Target sample size: 80
Recruitment status: Completed
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12909
Study type:  Observational
Study design:  Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
 
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Dr Neetha KIR   
Address:  256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru, Karnataka 560082 560082 Bangalore, KARNATAKA India
Telephone: 9741259494
Email: drshilpu@gmail.com
Affiliation:  Nethradhama Superspeciality Eye Hospital
Name: Dr Shilpa N   
Address:  256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru, Karnataka 560082 560082 Bangalore, KARNATAKA India
Telephone: 9741259494
Email: drshilpu@gmail.com
Affiliation:  Nethradhama Superspeciality Eye Hospital
Key inclusion & exclusion criteria
Inclusion criteria: Visual Fields of patients presenting to Nethradhama Superspeciality Eye hospital and have undergone a detailed eye examination including visual acuity measurement, slit lamp evaluation, Intra Ocular Pressure(IOP) measurement, stereoscopic fundus evaluation and Humphrey Swedish Interactive Test Algorithm (SITA) Standard visual field evaluation.
Exclusion criteria: Visual fields of participants with-

•a history of intraocular surgery other than uncomplicated cataract ,glaucoma or combined surgery

•secondary causes of elevated IOP (e.g. iridocyclitis, trauma)

•other intraocular diseases affecting the visual field (e.g. retinal diseases/lesions)

•medications known to affect visual field sensitivity

•neurological causes of visual field defects

•All visual fields with poor reliability



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- Glaucoma, Glaucoma suspect
Intervention(s)
Primary Outcome(s)
â?¢Calculate the mean, standard deviation and range of VFI in each stage of glaucomatous damage.

â?¢Test if VFI is significantly different among the different stages of Glaucomatous damageTimepoint: Single time point at the time of conducting the test
Secondary Outcome(s)
â?¢Calculate the mean of Mean Deviation (MD) and Pattern Standard Deviation (PSD) in each stage of glaucomatous damage

â?¢correlation between VFI and MD, VFI and PSD, VFI and Visual Acuity

Timepoint: Single time point
Secondary ID(s)
NIL
Source(s) of Monetary Support
Nethradhama Superspeciality Eye Hospital 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru, Karnataka 560082
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 26/08/2015
Contact:
Nethradhama Superspeciality Eye Hospital Institutional Ethics Committee (IEC)
Results
Results available:
Date Posted:
Date Completed: 31/05/2016
URL:
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